Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
58
Countries
7
Sites
13
Cancer
To monitor the safety and tolerability of study intervention(s)
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 8 Mar 2022 → ongoing
- Decision date (initial)
- 2024-08-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Pfizer Inc
External identifiers
- EU CT number
- 2023-509466-38-00
- EudraCT number
- 2021-002457-29
- ClinicalTrials.gov
- NCT05059522
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety
To monitor the safety and tolerability of study intervention(s)
Conditions and MedDRA coding
Cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1. Any participant who is receiving study treatment and deriving significant clinical benefit (as determined by the Principal Investigator) or is in the safety and/or survival follow-up period in a Pfizer-sponsored Avelumab Parent Study.
- 2. Participants must agree to follow the reproductive criteria as outlined in Appendix 4 (Section 10.4.1 for males and Section 10.4.2 for females) of the applicable Avelumab Continuation Sub-Study Protocol.
- 3. Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the appliable Avelumab Continuation Sub- Study Protocol.
- 4. Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion criteria 2
- 1. Female participants who are pregnant or breastfeeding.
- 2. Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- AEs leading to permanent discontinuation of study intervention
- All SAEs
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
SUB25427 · Substance
- Active substance
- Axitinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 36000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging and labeling for clinical trials
SUB25427 · Substance
- Active substance
- Axitinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 36000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging and labeling for clinical trials
SUB180394 · Substance
- Active substance
- Talazoparib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1800 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging and labeling for clinical trial
SUB180394 · Substance
- Active substance
- Talazoparib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1800 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging and labeling for clinical trial
SUB180078 · Substance
- Active substance
- Avelumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clinical trial packaging and labeling; Final batch release
SUB181272 · Substance
- Active substance
- Lorlatinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging and labeling for clinical trial
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 66 Hudson Boulevard East
- City
- New York
- Postcode
- 10001-2189
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | Other, E-data capture |
Locations
7 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 1 | 1 |
| Denmark | Ended | 1 | 1 |
| France | Ended | 1 | 1 |
| Hungary | Ended | 1 | 1 |
| Italy | Ongoing, recruitment ended | 3 | 4 |
| Poland | Ongoing, recruitment ended | 1 | 1 |
| Spain | Ongoing, recruitment ended | 6 | 4 |
| Rest of world
Korea, Republic of, Russian Federation, United States, United Kingdom, Taiwan, Mexico, Canada, Australia, Israel, Japan, New Zealand
|
— | 44 | — |
Investigational sites
Institut De Cancerologie De Lorraine
N/A, 6 Avenue De Bourgogne, 54500, Vandouvre Les Nancy
Orszagos Onkologiai Intezet
Országos Onkológiai Intézet Department: Kemoterápia B, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Azienda Ospedaliero Universitaria Delle Marche
Clinica Oncologica, Via Conca 71, 60126, Ancona
Humanitas Mirasole S.p.A.
UO Oncologia medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione IRCCS Istituto Nazionale Dei Tumori
N/A, Via Giacomo Venezian 1, 20133, Milan
Fondazione IRCCS Istituto Nazionale Dei Tumori
Struttura Complessa Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
N/A, Ul. Woloska 137, 02-507, Warsaw
Hospital Universitari Vall D Hebron
N/A, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
START Madrid FJD.Phase 1 Trials, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Edificio General Servicio de Oncologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Virgen De Valme
Ampliacion. Unidad de Oncologia. Planta baja, Avenida Bellavista S/n, 41014, Sevilla
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2022-04-14 | 2026-03-20 | 2022-04-19 | 2024-03-27 | |
| Denmark | 2022-11-23 | 2024-09-24 | 2022-12-07 | 2024-03-27 | |
| France | 2022-03-10 | 2026-01-14 | 2022-03-29 | 2024-03-27 | |
| Hungary | 2022-06-10 | 2024-09-02 | 2022-06-27 | 2024-03-27 | |
| Italy | 2022-07-07 | 2022-07-14 | 2024-03-27 | ||
| Poland | 2022-11-02 | 2022-11-17 | 2024-03-27 | ||
| Spain | 2022-03-08 | 2022-03-10 | 2024-03-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 86 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol Sub-Study B9991001C_2023-509466-38-00_B9991046_EN_public | Amd1 |
| Protocol (for publication) | D1 Protocol Sub-Study B9991003C_2023-509466-38-00_B9991046_EN_public | NA |
| Protocol (for publication) | D1 Protocol Sub-Study B9991005C_2023-509466-38-00_B9991046_EN_public | Amd2 |
| Protocol (for publication) | D1 Protocol Sub-Study B9991009C_2023-509466-38-00_B9991046_EN_public | Amd2 |
| Protocol (for publication) | D1 Protocol Sub-Study B9991023C_2023-509466-38-00_B9991046_EN_public | Amd1 |
| Protocol (for publication) | D1 Protocol Sub-Study B9991025C_2023-509466-38-00_B9991046_EN_version Amd1_public | Amd1 |
| Protocol (for publication) | D1 Protocol Sub-Study B9991032C_2023-509466-38-00_B9991046_EN_public | Amd1 |
| Protocol (for publication) | D1 Protocol_2023-509466-38-00_B9991046_EN_public | Amd1 |
| Protocol (for publication) | D1_PACL_2023-509466-38-00_B9991046_EN_public | NA |
| Protocol (for publication) | D1_PACL_Sub-Study B9991001C_2023-509466-38-00_B9991046_EN_public | NA |
| Protocol (for publication) | D1_PACL_Sub-Study B9991003C_2023-509466-38-00_B9991046_EN_public | NA |
| Protocol (for publication) | D1_PACL_Sub-Study B9991005C_2023-509466-38-00_B9991046_EN_public | NA |
| Protocol (for publication) | D1_PACL_Sub-Study B9991009C_2023-509466-38-00_B9991046_EN_public | NA |
| Protocol (for publication) | D1_PACL_Sub-Study B9991023C_2023-509466-38-00_B9991046_EN_public | NA |
| Protocol (for publication) | D1_PACL_Sub-Study B9991025C_2023-509466-38-00_B9991046_EN_public | NA |
| Protocol (for publication) | D1_PACL_Sub-Study B9991032C_2023-509466-38-00_B9991046_EN_public | NA |
| Protocol (for publication) | D2 PACL Med Escalation Process_2023-509466-38-00_B9991046_EN_public | NA |
| Recruitment arrangements (for publication) | B9991046_blank file_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | B9991046_PH file_SM1_Recruitment completed | N/A |
| Recruitment arrangements (for publication) | B9991046_PH file_SM1_Recruitment completed | N/A |
| Recruitment arrangements (for publication) | B9991046_PH file_SM1_Recruitment completed | N/A |
| Recruitment arrangements (for publication) | B9991046_PH file_SM1_Recruitment completed | n/a |
| Recruitment arrangements (for publication) | B9991046_PH file_SM1_Recruitment completed | N/A |
| Recruitment arrangements (for publication) | B9991046_PH file_SM1_Recruitment completed | N/A |
| Subject information and informed consent form (for publication) | L1_Main ICD_B9991046_ B9991009C_FR-FR_Public | 6.2.0 |
| Subject information and informed consent form (for publication) | L1_Main ICD_B9991046_B9991001C_ES-ES_Public | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICD_B9991046_B9991001c_PL-PL_Public | 4_0 |
| Subject information and informed consent form (for publication) | L1_Main ICD_B9991046_B9991003c_IT-IT_Public | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_B9991046_B9991001C_DK-DK_Public | 2.2 |
| Subject information and informed consent form (for publication) | L1_Main ICF_B9991046_B9991025C_HU-HU_Public | N/A |
| Subject information and informed consent form (for publication) | L10_PPRIF_B9991046_B9991032c_ES-ES_Public | 1.1.0 |
| Subject information and informed consent form (for publication) | L2_PPRIF_B9991046_ B9991025C_HU-HU_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_PPRIF_B9991046_B9991001C_DK-DK_Public | 1.2 |
| Subject information and informed consent form (for publication) | L2_PPRIF_B9991046_B9991001c_ES-ES_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_PPRIF_B9991046_B9991001c_PL-PL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_PPRIF_B9991046_B9991009C_FR-FR_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_Privacy Supplement_B9991046_B9991003c_IT-IT_Public | 2.0 |
| Subject information and informed consent form (for publication) | L3_Main ICD_B9991046_B9991005C_ES-ES_Public | 9.1.0 |
| Subject information and informed consent form (for publication) | L3_PPRIF_B9991046_B9991003c_IT-IT_Public | 2.0 |
| Subject information and informed consent form (for publication) | L3_Privacy Supplement_B9991046_B9991009C_FR-FR_Public | N/A |
| Subject information and informed consent form (for publication) | L3_PSIC_B9991046_ B9991025C_HU-HU_Public | 1.1 |
| Subject information and informed consent form (for publication) | L3a_Main ICD_B9991046_B9991025C_BE-EN_Public | N/A |
| Subject information and informed consent form (for publication) | L3b_Main ICD_B9991046_B9991025C_BE-FR_Public | N/A |
| Subject information and informed consent form (for publication) | L3c_Main ICD_B9991046_B9991025C_BE-NL_Public | N/A |
| Subject information and informed consent form (for publication) | L4_Appendix A_B9991046_B9991003c_IT-IT_Public | 1.0 |
| Subject information and informed consent form (for publication) | L4_PPRIF_B9991046_B9991005c_ES-ES_Public | 1.1.0 |
| Subject information and informed consent form (for publication) | L4a_PPRIF_B9991046_B9991025C_BE-EN_Public | 1.0 |
| Subject information and informed consent form (for publication) | L4b_PPRIF_B9991046_B9991025C_BE-FR_Public | 1_0 |
| Subject information and informed consent form (for publication) | L4c_PPRIF_B9991046_B9991025C_BE-NL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L5_Main ICD_B9991046_B9991009C_ES-ES_Public | 6.1.0 |
| Subject information and informed consent form (for publication) | L5_Main ICD_B9991046_B9991032c_IT-IT_Public | N/A |
| Subject information and informed consent form (for publication) | L6_PPRIF_B9991046_B9991009c_ES-ES_Public | 1.1.0 |
| Subject information and informed consent form (for publication) | L6_PPRIF_B9991046_B9991032c_IT-IT_Public | 1.0 |
| Subject information and informed consent form (for publication) | L7_Main ICD_B9991046_B9991023C_ES-ES_Public | 4.1.0 |
| Subject information and informed consent form (for publication) | L8_PPRIF_B9991046_B9991023c_ES-ES_Public | 1.1.0 |
| Subject information and informed consent form (for publication) | L9_Main ICD_B9991046_B9991032c_ES-ES_Public | 2.2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC_Bavencio_Avelumab_B9991046_EN | NA |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_2023-509466-38-00_B9991046_BE_DE_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_2023-509466-38-00_B9991046_BE_FR_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_2023-509466-38-00_B9991046_BE_NL_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_2023-509466-38-00_B9991046_ES_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_2023-509466-38-00_B9991046_FR_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_2023-509466-38-00_B9991046_HU_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_2023-509466-38-00_B9991046_IT_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_2023-509466-38-00_B9991046_PL_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991001C_2023-509466-38-00_B9991046_ES_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991001C_2023-509466-38-00_B9991046_PL_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991003C_2023-509466-38-00_B9991046_IT_public | NA |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991005C_2023-509466-38-00_B9991046_ES_public | Amd2 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991009C_2023-509466-38-00_B9991046_BE_DE_public | Amd2 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991009C_2023-509466-38-00_B9991046_BE_FR_public | Amd2 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991009C_2023-509466-38-00_B9991046_BE_NL_public | Amd2 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991009C_2023-509466-38-00_B9991046_ES_public | Amd2 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991009C_2023-509466-38-00_B9991046_FR_public | Amd2 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991023C_2023-509466-38-00_B9991046_ES_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991023C_2023-509466-38-00_B9991046_IT_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991025C_2023-509466-38-00_B9991046_BE_DE_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991025C_2023-509466-38-00_B9991046_BE_FR_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991025C_2023-509466-38-00_B9991046_BE_NL_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991025C_2023-509466-38-00_B9991046_HU_public | 1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991032C_2023-509466-38-00_B9991046_BE_DE_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991032C_2023-509466-38-00_B9991046_BE_FR_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991032C_2023-509466-38-00_B9991046_BE_NL_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991032C_2023-509466-38-00_B9991046_ES_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991032C_2023-509466-38-00_B9991046_FR_FR_public | Amd1 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study B9991032C_2023-509466-38-00_B9991046_IT_public | Amd1 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-10 | Spain | Acceptable with conditions 2024-08-07
|
2024-08-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-19 | Spain | Acceptable with conditions 2024-08-07
|
2024-09-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-08 | Spain | Acceptable 2025-02-25
|
2025-02-25 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-05 | Acceptable 2025-02-25
|
2025-06-05 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-18 | Spain | Acceptable with conditions 2025-11-11
|
2025-11-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-06 | Spain | Acceptable 2026-04-08
|
2026-04-10 |